1. Standard Operating Procedures § 160.81
40 CFR Part § 160 Subpart E
Standard Operating Procedures §

2. What is a Standard Operating Procedure?
My Definition
An established written document that is used to standardize a procedure
You can Ask yourself:
Have I done this procedure before?
Will I do this again?
Does it need to be done the same way each time?
Do other people need to do it the same way?
Do other people need to understand what I am doing?

3. Why do we need SOPs? Everyone is “on the same page”
No question on how to complete a task
No question on how a task was completed
Anyone can read and understand the procedure

4. What kind of SOPs are needed?
(b) lists the minimum-
Routine instrument maintenance?
Glassware washing?
QAU?
Computer?
SOP for SOPs?
Analytical method?
Specific procedures for initial research project?

5. GLP Requirements for SOPs
Testing facility shall have SOPs
Management is satisfied that the SOPs are adequate to insure quality and integrity of data
Management approval
in writing / signatures
Significant changes in SOPs shall be authorized in writing by management

6. GLP Requirements for SOPs
All deviations in a study from SOPs shall be authorized by Study Director and documented in the raw data.
Who is responsible for documenting SOP changes?
Study Director ?
Management ?
QAU ?

7. GLP Requirements for SOPs
Each laboratory / study area shall have immediately available SOPs relative to the operations being performed
Published literature may be used as a supplement to SOPs

8. How are SOPs written? User friendly General vs. specific
Use of manuals
Check lists
Dynamic documents
Don’t be afraid to change them

9. Who can / should write SOPs ?
Study Director?
Management?
Quality Assurance Unit?
Technician?
Janitor?

10. Historical SOPs SOPs are dynamic documents
They can / should be changed to meet the needs of the operation
All revisions of each SOP including date revised shall be maintained.
Why?
Where?

11. SOP Dissemination Who gets each SOP Who disseminates
Hard copies vs. electronic copies
SOP review

12. SOP Exercise / Discussion
Does it meet GLP standards?
Is it a useable document?
Any problems?
How would you change?